Title:
SYSTEM FOR DESIGNATING, DISPLAYING AND SELECTING TYPES OF PROCESS PARAMETERS AND PRODUCT OUTCOME PARAMETERS
Document Type and Number:
Japanese Patent JP2016106302
Kind Code:
A
Abstract:
PROBLEM TO BE SOLVED: To implement quality by design methods in pharmaceutical manufacturing processes.SOLUTION: Described is the display on a visual display device of one or more first visual indicators that indicate that one or more first process parameters of a process are critical process parameters. The critical process parameters are displayed on the visual display device as part of a hierarchical data structure.SELECTED DRAWING: Figure 28
Inventors:
JUSTIN NEWAY
Application Number:
JP2016005393A
Publication Date:
June 16, 2016
Filing Date:
January 14, 2016
Export Citation:
Assignee:
AEGIS ANALYTICAL CORP
International Classes:
G06F3/0484; G06F3/0481; G06Q50/04
Domestic Patent References:
| JP2004504661A | 2004-02-12 | |||
| JP2005346444A | 2005-12-15 | |||
| JP2008209988A | 2008-09-11 | |||
| JPH06309584A | 1994-11-04 | |||
| JP2007048291A | 2007-02-22 |
Foreign References:
| WO2007017738A2 | 2007-02-15 | |||
| US6725230B2 | 2004-04-20 | |||
| US20070135944A1 | 2007-06-14 |
Other References:
ROBIN E. MCDERMOTT他 著、原田陽史 訳, ＦＭＥＡの基礎 第２版, vol. 第２版, JPN6016048677, 22 September 2010 (2010-09-22), JP, pages 19 - 28, ISSN: 0003464238
"Quality by Design using an Integrated Active Pharmaceutical Ingredient - Drug Product Approach to De", PHARMACEUTICAL ENGINEERING[ONLINE], vol. 30, no. 4, JPN7017002493, July 2010 (2010-07-01), US, pages 1 - 16, ISSN: 0003609884
原薬ＧＭＰのガイドラインについて[ONLINE], JPN6017028619, 2 November 2001 (2001-11-02), pages 全文, ISSN: 0003609885
製剤開発に関するガイドラインの改定について[ONLINE], JPN6017028620, 28 June 2010 (2010-06-28), ISSN: 0003609886
品質リスクマネジメントに関するガイドライン[ONLINE], JPN6017028622, 1 September 2006 (2006-09-01), ISSN: 0003609887
医薬品品質システムに関するガイドラインについて[ONLINE], JPN6017028624, 19 February 2010 (2010-02-19), ISSN: 0003609888
"Quality by Design using an Integrated Active Pharmaceutical Ingredient - Drug Product Approach to De", PHARMACEUTICAL ENGINEERING[ONLINE], vol. 30, no. 4, JPN7017002493, July 2010 (2010-07-01), US, pages 1 - 16, ISSN: 0003609884
原薬ＧＭＰのガイドラインについて[ONLINE], JPN6017028619, 2 November 2001 (2001-11-02), pages 全文, ISSN: 0003609885
製剤開発に関するガイドラインの改定について[ONLINE], JPN6017028620, 28 June 2010 (2010-06-28), ISSN: 0003609886
品質リスクマネジメントに関するガイドライン[ONLINE], JPN6017028622, 1 September 2006 (2006-09-01), ISSN: 0003609887
医薬品品質システムに関するガイドラインについて[ONLINE], JPN6017028624, 19 February 2010 (2010-02-19), ISSN: 0003609888
Attorney, Agent or Firm:
Takaki Nishijima
Disciple Maru Ken
Shinichiro Tanaka
Fumiaki Otsuka
Hiroyuki Suda
Hiroshi Uesugi
Naoki Kondo
Hiroshi Oura
Disciple Maru Ken
Shinichiro Tanaka
Fumiaki Otsuka
Hiroyuki Suda
Hiroshi Uesugi
Naoki Kondo
Hiroshi Oura